MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for HAND PIECE FOR PIEZOELECTRIC SYSTEM 05.001.401 manufactured by Synthes Selzach.
[72800067]
Device used for treatment, not diagnosis. Device is not distributed in the united states, but is similar to device marketed in the usa (b)(4). Device is an instrument and is not implanted/explanted. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. (b)(6). Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[72800068]
Device report from synthes on an event in (b)(6) as follows: it was reported that the device 05. 001. 401 was submitted for service from affiliate in (b)(6). The following condition were reported on a synergy form: device leaking. There were no injuries, patient user involvement or surgery delay or need for additional medical intervention reported. If any additional information should became available, this notification will be updated accordingly. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[75227280]
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[80345399]
According to service record note, it states that there is a joint problem is on the motor head. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[86990276]
A device history record review was performed for the subject device serial number (b)(4). Manufacturing location: (b)(4). Date of manufacture: 04. 02. 2015. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. Previous to the current issue reported, the device has not been serviced; hence no service history record review is possible. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2017-11265 |
| MDR Report Key | 6487696 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-03-15 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2015-04-02 |
| Date Added to Maude | 2017-04-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHNACKERWEG 5 |
| Manufacturer City | SELZACH CH2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAND PIECE FOR PIEZOELECTRIC SYSTEM |
| Generic Name | SAW |
| Product Code | HSO |
| Date Received | 2017-04-12 |
| Returned To Mfg | 2017-04-24 |
| Catalog Number | 05.001.401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES SELZACH |
| Manufacturer Address | BOHNACKERWEG 5 SELZACH PA CH2545 SZ CH2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |